The US Food and Drug Administration is testing a new response system to boost the drug industry

إدارة الغذاء والدواء الأمريكية تختبر نظام استجابة جديدًا لتعزيز صناعة الدواء

In the context of the continuous pursuit of raising the level of health, and the efforts made to establish an integrated health system, develop the pharmaceutical and vaccine industry, and find regulatory ways that would facilitate that industry – in this article we highlight an experimental mechanism that has overcome many obstacles and brought developers closer to regulatory departments. In order to facilitate pharmaceutical manufacturing operations and support sustainable development in this vital sector.

The US Food and Drug Administration has launched a pilot program aimed at facilitating the drug manufacturing process by accelerating communication between the agency and drug developers, and also allows companies to obtain quick answers to their questions after official meetings.

Communication betweenAgencyand drug developers

The new initiative is called the “Meeting Minute Clarification Opportunity,” and it allows drug sponsors to request clarification of any points raised during their official meetings with the FDA.

Instead of waiting for additional appointments or engaging in lengthy correspondence, these companies can send a follow-up question via e-mail and obtain an answer from the relevant department within the administration within only three working days.

وكذلك تهدف هذه الخطوة إلى تقليل التأخير والغموض التنظيمي، والعمل على تسريع مسار تطوير الأدوية الجديدة، حيث يُدار البرنامج من قِبل مكتب الأدوية الجديدة بإدارة الغذاء والدواء، وقد أفادت الإدارة أنَّ المشاركين الأوائل قد حصلوا بالفعل على توضيحات عاجلة.
“Time is a valuable resource in this industry,” said FDA Commissioner Marty McCurry, noting that drug developers often face repeated delays while trying to understand regulatory guidance. Which delays the drug manufacturing process.

He added: “Our goal is to provide companies with a clear and quick opinion; So that they can focus on what they do best: bringing more treatment and medical innovations to people”.

Pilot Program Management

This pilot program, which was launched in October of this year, is managed by the Office of New Drugs at the Food and Drug Administration. Food and Drug Administration officials said: This step comes within a broader modernization plan aimed at simplifying the drug manufacturing and development process, and enhancing communication with sponsoring companies across the agency’s various centers.

With the continuation of the pilot program, the Food and Drug Administration hopes that simplifying the pace of communication and clarifying regulatory points will contribute to accelerating the drug manufacturing process and developing new types of treatment, and reducing delays and errors, so that medical innovation reaches more quickly the patients who need it.

An Egyptian regulatory model to facilitate the pharmaceutical industry

Similar to this mechanism, we highlight a regulatory model launched by the Egyptian Medicines Authority, which is the “Regulatory Guide to Approval Practices During Drug Registration”; With the aim of accelerating the registration of medicines, and ensuring their high quality access to the local market more quickly.

The guide focuses on benefiting from previous assessments of authoritative international bodies and the World Health Organization, which allows the body to effectively monitor and continue follow-up. The system also includes two main paths:

• Verification path based on previous approvals from reference bodies.
• Abbreviated evaluation pathway that partly reviews documents taking into account those international evaluations.

This framework also ensures flexibility in cases of health emergencies or drug shortages, while maintaining the full responsibility of the authority in making final decisions; This reflects Egypt’s trend towards adopting global practices to accelerate pharmaceutical innovation and raise the profile of the pharmaceutical industry, as well as improving access to treatment for patients.

Despite the methodological difference between the two mechanisms, they share one strategic goal; It is to modernize organizational efficiency to speed up the drug manufacturing and development process and facilitate the access of medicines to patients. Which helps implement modern organizational governance, and contributes to achievingSustainable Development Goals (SDGs).

In conclusion, such initiatives in both the United States and Egypt provide a concrete model for transforming pharmaceutical management towards greater efficiency and greater flexibility. By simplifying communication mechanisms between regulatory bodies and drug developers; Medical innovations can now be transferred from the development stage to patients faster and safer.

Therefore,The Earth Guards Foundationshed light on these pioneering organizational models in our world, based on their role in achieving the goals of sustainable development through their various dimensions, especially the social dimension.